Table 3.
Scheduling | Screening and enrolment | Baseline and treatment day 1 | Treatment day 2* | 48 hours | 1 week | 3 weeks | 6 weeks | 12 weeks |
3 weeks before baseline | 3 weeks after enrolment | 1 day after baseline | 2 days after baseline | 1 week after baseline | 3 weeks after baseline | 6 weeks after baseline | 12 weeks after baseline | |
Visit type | Clinic | Clinic | Clinic | Phone call | Phone call | Phone call | Clinic | Clinic |
Eligibility screen | ✓ | |||||||
Informed consent | ✓ | |||||||
FMT treatment | ✓ | ✓ | ||||||
Adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Tolerability questionnaire | ✓ | |||||||
Background questionnaire | ✓ | |||||||
Eating disorder symptoms (EDEQ)66 | ✓ | ✓ | ✓ | |||||
Depression symptoms (PHQ-9)60 | ✓ | ✓ | ✓ | ✓ | ||||
Anxiety symptoms (GAD-7)67 | ✓ | ✓ | ✓ | |||||
Stool sample | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Blood sample | ✓ | ✓ | ✓ | |||||
Whole-body composition scan (DXA) | ✓ | ✓ |
*Study timeline is based on a 2 day treatment schedule. If a participant decides to spread their treatment over four consecutive days, the tolerability questionnaire will be administered on the final day of treatment (day 4) and the 48 hour phone call will be 24 hours after the final dose of capsules.
DXA, dual-energy X-ray absorptiometry; EDEQ, Eating Disorder Examination Questionnaire; FMT, faecal microbiome transfer; GAD-7, General Anxiety Disorder 7-item scale; PHQ-9, Patient Health Questionnaire 9.